Summary:
Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on lack of written policies and procedures for review and interview with the Technical Supervisor (TS-1), the laboratory failed to establish policies and procedures for patient preparation, specimen collection, specimen labeling, specimen storage and preservation, conditions for specimen transportation, specimen processing, specimen acceptability and rejection, and specimen referral. Findings include: 1. The laboratory began grossing patient specimens in July 2023 under the subspecialty of Histopathology. The laboratory reports an annual test volume of 5,500. 2. No documentation was presented for review during the survey conducted on 6/25/25 to indicate the laboratory established policies and procedures for patient preparation, specimen collection, specimen labeling, specimen storage and preservation, conditions for specimen transportation, specimen processing, specimen acceptability and rejection, and specimen referral. 3. The TS-1 interviewed on 6/25/25 at 9:15 AM confirmed the laboratory failed to provide evidence of the above referenced policies and procedures at the time of the survey Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --